Tag Archives: BIOCON

Biocon Q1 ’20 (FY ’20) Earnings Update

Biocon hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and provided brief updates on its biosimilar insulin development programs. Unsurprisingly, there were many analyst questions focusing on pricing strategy and interchangeability for bs-glargine, although Biocon’s senior management were reluctant to provide details. Below, FENIX provides highlights from the earnings call as well as brief thoughts on what approval for interchangeability in the US may look like.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Biocon’s Malaysian Facility Passes Pre-Approval Glargine FDA Inspection

Biocon has issued a press release announcing they received the FDA “Establishment Inspection Report” for the bs-glargine pre-approval inspection of its Malaysian manufacturing facility. The closing of the inspection comes after several failed inspections over the past few years. Below, FENIX provides thoughts on Biocon passing its inspection, including the impact on the impending June 2020 bs-glargine FDA action date.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Mylan Q4 ’19 Earnings Update; Bs-glargine Briefly Discussed

Mylan hosted its Q4 and FY 2019 earnings call and provided updates to its business. The vast majority of the call revolved around the pending merger with Pfizer’s Upjohn. Of note, Mylan briefly discussed the US regulatory status of its bs-glargine and bs-aspart (in partnership with Biocon). Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon/Mylan Bs-Glargine PDUFA in June 2020; Biocon CY Q4 ’19 (FY Q3 ’20) Earnings Update

Biocon hosted its CY Q4 ’19 (FY Q3 ’20) earnings call and provided updates to the ongoing bs-glargine US review including a more specific FDA approval and launch timeline. Additionally, Biocon discussed how recent legislation has aided the bs-glargine review given the impending March 23, 2020 insulin reclassification. Below, FENIX provides insight and context on the Biocon/Mylan bs-glargine product.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Would AZ, Teva, or Mylan/Upjohn Buy Sanofi’s DCV Business?

Earlier this week, Sanofi hosted its 2019 Capital Markets Day and the company disclosed plans to re-structure its diabetes and cardiovascular business. As part of the discussion, senior management entertained the idea that it would consider divesting the business and/or its assets if it found the right suitor. Below, FENIX provides analysis of companies who could potentially be interested in Sanofi’s DCV assets and why AstraZeneca, Teva, or even Viatris (Mylan/Upjohn) could be viable options.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan and BD Q3 ’19 Earnings Updates

Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Biocon Ph1 Oral Insulin Trial

A CT.gov record for a new Ph1 trial evaluating Biocon’s oral insulin Tregopil has been observed. Of note, the trial is being conducted by Profil in Mainz, Germany. Below, FENIX provides thoughts and insights into insulin Tregopil’s development including the challenges and commercial opportunity particularly around cold chain storage in underdeveloped geographies.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon CY Q3 ’19 (FY Q2 ’20) Earnings Update

Biocon hosted its CY Q3 ’19 (FY Q2 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine, bs-aspart and bs-rHI. Recall, Biocon/Mylan received a CRL from FDA for bs-glargine submission in September 2019 (previous FENIX insight). Of note, Biocon indicated it is confident in resolving the CRL and anticipates FDA approval prior to the March 2020 insulin reclassification. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan Faces Setback in Sanofi Bs-Glargine Lawsuit

According to new court documents, the presiding judge in the Sanofi v. Mylan glargine lawsuit has denied Mylan’s request to rule two Lantus formulation patents invalid. The trial to settle the ongoing patent dispute is scheduled to start on December 2, 2019. Below, FENIX provides thoughts on the judge’s ruling and the potential impact on the Mylan/Biocon bs-glargine US launch timeline.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.